510(k) DEN150053
DEN150053 is an FDA 510(k) premarket notification submitted by Safe Obstetric Systems, Ltd. for the device "FETAL PILLOW". The FDA issued a decision of De Novo Granted on July 27, 2017. The device falls under product code PWB (Fetal Head Elevator), a Class II device regulated under 21 CFR 884.4350.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 27, 2017
- Date Received
- November 18, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fetal Head Elevator
- Device Class
- Class II
- Regulation Number
- 884.4350
- Review Panel
- OB
- Submission Type
To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.